Many women who took Zofran during pregnancy had no idea that it was prescribed off-label, or in other words it wasn’t approved by the FDA to treat morning sickness.
The majority of women who take Zofran only take it in the first trimester and only for a few days to alleviate nausea during early pregnancy. But morning sickness can be dangerous for a small percentage of women so they continue using the drug throughout their pregnancy.
One woman, Marquita Smiley, took it a few times a week into her second trimester, according to a news article published on June 1, 2016 in the Brimmingham News. During her 5th month of pregnancy an ultrasound showed her baby’s heart was underdeveloped. Just days after her son was born he had open-heart surgery and at two months of age he had a heart transplant. When Smiley say a an ad claiming that Zofran causes heart birth defects, she filed a lawsuit against the makers of Zofran. Smiley says if she had known of the risk of birth defects, “I would not have placed him at risk,” she told the newspaper.